Yee Wei Tan
Study Coordinator at Info Kinetics- Claim this Profile
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Chinese Native or bilingual proficiency
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English Full professional proficiency
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Bahasa Malaysia Professional working proficiency
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Cantonese Limited working proficiency
Topline Score
Bio
Credentials
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Good Clinical Practice
The Ministry of Health MalaysiaOct, 2021- Oct, 2024
Experience
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Info Kinetics
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Malaysia
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Study Coordinator
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Dec 2020 - Present
• Manage multiregional phase III & IV studies with different CROs and sponsors. Familiarize with variousprotocols in oncology, cardiology, and nephrology therapeutic areas.• Assist sponsor to approach potential investigators for feasibility studies. Assess and review study protocol; clarifies concerns and questions with investigator and sponsor.• Organize and participate in Site Selection Visit, Site Initiation Visit, Global Investigator Meeting, SiteMonitoring Visit and Site Close Out Visit.• Assist Investigator in subject recruitment and retention, inform consenting, and conduct study visits inaccordance with GCP and SOPs to ensure subject safety and identity are protected.• Maintain source documents, essential documents and reports to ensure data integrity according to Good Documentation Practice.• Submit essential documents, amendments and safety issues (e.g., SAE/ SUSAR reporting) to EthicsCommittee pertaining to clinical trial in a timely manner.• Collect, handle, store, transport, and dispose biological samples and laboratory kits according to GoodLaboratory Practice and IATA Dangerous Good Regulations.• Manage site inventory, storage condition, disposal, and return of investigational medicinal product andlaboratory kits according to GCP and SOPs.• Submit biological samples import/ export permit applications with relevant Health Office.• Coordinate clinical activities with multi-departmental site staffs between Gleneagles Hospital Penang and Mount Miriam Cancer Hospital.• Participated in Covid-19 vaccine trials as the role of Clinical Research Associate during site start up phases. Show less
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Clinical Research Associate
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Mar 2021 - Dec 2021
- Participated in Covid-19 vaccine trials as the role of Clinical Research Associate. - Conducted SSV and start-up activities.- Assisted in setting up and maintaining Trial Master File.- Assisted in smooth RA and EC submission.
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Education
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The University of Nottingham Malaysia Campus
Pharmaceutical and health science, Pharmaceutical Sciences -
SMK Pai Chee
SPM